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SEEK, a privately owned biopharmaceutical company specializing in immunology, announces today that it has completed a Phase Ib/II clinical trial of its HIV-v vaccine which demonstrates a one log (approx 90 percent) difference in viral count in HIV-infected people compared with the placebo group, after just a single vaccine injection.

Gregory Stoloff, CEO of SEEK, commented: "This is the first time ever that an HIV vaccine has shown such a meaningful result in a human clinical trial. The next step will be to progress this to final human trials and determine the optimum dose and dosing regime to further enhance the vaccine's efficacy."

The development of an effective vaccine against HIV has been extremely difficult because the HIV virus constantly mutates. However, SEEK's HIV-v vaccine targets only the conserved regions in the internal proteins of the HIV virus which remain constant across all HIV strains. It is the first vaccine to generate both strong T-cell and antibody responses to eliminate HIV-infected cells and thus neutralise the HIV virus. These unique features mean that the vaccine, while initially tested in an early stage of the disease as a therapeutic, could also be effective as a prophylactic, pending confirmation in a future trial.

Commenting on the results, Marta Boffito, MD, PhD, from the St. Stephen's Aids Trust and the principal investigator in the trial, said: "These are remarkable results which demonstrate HIV-v's safety and immunogenicity and, for the first time, a clinically relevant result, as seen in the one log reduction in viral titres. HIV has long reached pandemic status and, despite growing numbers on anti-retrovirals, we are in desperate need of both a prophylactic and therapeutic vaccine. This HIV-v vaccine definitely warrants further investigation in both these areas."

About the Phase Ib/II trial

The Phase Ib/II trial involved 55 HIV-positive volunteers across the UK, assessing safety and tolerability, as well as the effectiveness of the vaccine by monitoring blood viral load and CD4+ T-cell count, an immune cell which is specifically infected with HIV. The involvement of T and B cells of the immune system in response to the vaccine was assessed by measuring Interferon Gamma and IgG levels.

It was conducted at six centres in the UK:

1) North Manchester General Hospital; 2) Grahame Hayton Unit of the Royal London Hospital; 3) Elton John Centre at the Royal Sussex County Hospital; 4) Royal Hallamshire Hospital; 5) St. Stephen's Centre at the Chelsea and Westminster Hospital, London; and 6) St. Thomas' Hospital, London.

There were five patient groups in the trial: four vaccinated with HIV-v vaccine and one placebo. The four vaccinated groups were divided into low-dose with and without adjuvant and then a higher-dose with and without adjuvant.

Wilson Caparros Wanderley, Chief Scientific Officer of SEEK, added: "The results demonstrate that after a single immunizationthe HIV-v vaccine produces a very strong response from both the antibody and T cell immune systems to the conserved regions only. This is the first time that an antibody response was made to a conserved internal protein that appears on the cell surface during the life-cycle of the HIV virus."

Since the vaccine is synthetically manufactured, it will be inexpensive to produce and can be quickly manufactured in large quantities, making it viable for cost-effective widespread distribution in low-income countries.

SEEK will evaluate partnerships to undertake final human trials during 2012/13. It is expected that these will be therapeutic Phase III trials, which will recruit HIV-infected patients whose viral-load levels will be monitored to determine the optimal dose and dosing regime. All patients will then be switched to that dose and dosing regime and will be followed for the remainder of the trials. Due to the defined and easily-measurable end-points (such as viral-load levels) the trials are expected to be short in duration. If approved, the vaccine could be available to patients in 3-5 years time.

These data are being released to coincide with the 6th IAS Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2011), the world's largest open scientific conference on HIV/AIDS, being held in Rome from 17-20 July 2011. Held every two years, the IAS conference attracts about 5,000 delegates from all over the world. It is a unique opportunity for the world's leading scientists, clinicians, public health experts and community leaders to examine the latest developments in HIV-related research, and to explore how scientific advances can inform the global response to HIV/AIDS.

Notes

Background

The development of an effective vaccine against HIV has been extremely difficult because the HIV virus constantly mutates, changing the peptide sequences ("epitopes") of the viral structural proteins that it presents to the human immune system. This means that conventional approaches to the development of vaccines cannot be employed.

SEEK's HIV-v vaccine has been designed to specifically target only certain conserved regions of the viral proteins that are not subject to regular mutation. The advantage of this approach is that HIV-v only delivers those specific epitopes that are important in the host's immune response, whereas other vaccines employ whole proteins that have multiple internal and external epitopes and therefore can cause the immune system to direct its response against the wrong targets. With HIV-v, the immune system is primed to recognise and target only those regions within HIV proteins that are highly conserved and hence present in all recorded strains of this highly variable virus.

HIV-v Vaccine

SEEK's HIV-v vaccine can be quickly, easily and cost-effectively manufactured. The vaccine consists of a number of peptide sequences from viral proteins. These peptides are made synthetically, thus allowing for increased purity and more controlled dosing of the vaccine compared with conventional vaccines obtained from or delivered by genetically-modified organisms.

HIV Background/Economics

Human Immunodeficiency virus (HIV) is the causative agent for AIDS. Infection with this retrovirus causes a progressive failure of the immune system making the host susceptible to opportunistic infections and cancers.

Currently, there are more than 33 million people living with HIV/AIDS worldwide, according to the World Health Organization, the majority of them in sub-Saharan Africa. Since 1980 over 25 million people have died as a result of HIV/AIDS. Only 6.5 million out of an estimated 17million are eligible for anti-retroviral (ARV) treatment. UNAIDS estimates that $22bn a year will be required by 2015 to ensure universal access to treatment care and support by people living with HIV/AIDS.

If the therapeutic efficacy of this vaccine is confirmed in further human studies, newly-diagnosed people infected with HIV may benefit from immediate treatment rather than waiting until their health deteriorates to the status required to qualify for expensive anti-retroviral (ARV) treatment programmes. This would also reduce the risk of transmission and. provide a cost-effective means of achieving UNAIDS' declared objective in their Treatment 2.0 policy for AIDS, by making HIV treatment affordable for low-income countries, especially those hardest hit in sub-Saharan Africa.

SEEK is working with the Rush Foundation to incorporate an access agreement for low-income countries, particularly sub-Saharan Africa, within any partnership arrangement.

Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional. For more information, please read our terms and conditions.

This is exciting news. Hopefully, with optimum dosing, and possibly in combination with other therapeutic vaccines, it may be possible to wean people off meds for prolonged periods, and reduce viral loads to a point where it renders people non-infectious. Way too early to tell at this point, but it sounds promising.

I was reading another article about this vaccine online and it made a point of stating that >never before has any vaccine candidate been able to acheive the "functional cure" that this vaccine demonstrated in an animal model<

It went on to state clearly however that, this was SIV in monkeys and not HIV in humans and as we all know..people are not monkeys (at least most people).

I'll keep my fingers and everything else that I can cross crossed...the results seem good so far. The high dosed with the adjuvant seems to reduce viral loads by one log for almost 6 months. I'm looking forward to the results of the larger clinical 3 trials.

I say too if it works even for 1-2 years before needed a booster I say make it available within the next 5 years if that long. This way folks don't have to deal with serious side affects and toxicities related to HAART.

I don't recall any HIV therapeutic vaccine that's ready for clinical phase 3 trials except the Thai vaccine in 2009 that only conveyed a modest 31% protection from HIV. Although that may have been more preventative than therapeutic.

I say too if it works even for 1-2 years before needed a booster I say make it available within the next 5 years if that long. This way folks don't have to deal with serious side affects and toxicities related to HAART.

There are many good HAART regimens with limited toxicity and well known side effect profiles. Why is a relatively untested vaccine preferable?

One of the nice things about HAART is that it only lasts for a limited amount of time in your body -- so if something goes wrong you can just stop taking it and switch to something else. What would be your option here?

The entire idea of a vaccine is so that it is accessible to everyone that needs it worldwide. HAART is super costly and not accessible to everyone. This vaccine will be going into clinical 3 trials as early as next year. The clinal trials as outlned in the report will be short. Effectiveness of the vaccine in a larger population will be shown within the next 5 years. Furthermore it wont be costly like current HAART.

I would prefer to get a vaccine even if every two years instead of worrying about side effects of antiviral meds and taking meds daily for the rest of my life. As I'm am sure many others would do as well.

Here's some more useful/interesting information regarding this vaccine. It does sounds like this can replace ART (if successful) within the next 5 years depending on clinical trials and the financial aspect of the study. I haven't found any info on the pre-clinical stuff with monkeys as mentioned earlier in the thread, but if someone posted a link, I would appreciate it.

SEEK's Immune-Boosting HIV Vaccine Jumping to Phase III

LONDON â?? SEEK Ltd. has reached clinical proof of efficacy in a Phase Ib/II trial of its HIV-v vaccine, showing a 90 percent reduction in viral load in HIV-infected volunteers.

The trial, at six centers in the UK, involved 55 HIV-positive subjects.

Although their immune systems were damaged by the virus, they all had CD-4 counts above 350, which is the point at which anti-retroviral drugs start to be administered. The 90 percent reduction in viral load was achieved in comparison to normal disease progression in subjects who received placebo, and occurred after a single vaccination.

"These are incredible results," Gregory Stoloff, CEO told BioWorld Today, saying this is the first time it has been shown a "properly structured" T- and B-cell vaccine can work.

The achievement is all the more remarkable given previous high-profile failures of HIV vaccines in development. As with flu, the difficulty in constructing an effective vaccine is due to the constant mutation of the HIV virus. SEEK's HIV-v vaccine targets regions of the virus that are conserved across all HIV strains, and Stoloff said it would be impossible for the virus to mutate so that the HIV-v vaccine became ineffective. "These are the parts [HIV] needs to enter CD-4 cells â?? if these changed it wouldn't be HIV anymore."

There were no safety concerns. Given the good signs of efficacy, Stoloff said, HIV-v is ready to go straight into Phase III.

SEEK is exploring three possible avenues for financing the trial. One is joining the London Stock Exchange. "We've spoken to investment banks about listing and had a positive response. We would never list the entire SEEK group, but would list the vaccines [portfolio]," Stoloff said.

The company is due to release Phase II data on its flu vaccine in the next few weeks, and Stoloff said they are "also excellent results," that highlight the strength of the vaccines platform technology and reinforce the case for listing this part of the company.

Another possibility is to find a commercial partner. "We've been talking to potential collaborators for the last six years. They all wanted to see human data. We are sending out these results to all potential partners today," Stoloff added. A third option would be to strike a deal with a charitable foundation that is active in this area.

The Phase III trial envisaged by SEEK would, like the Phase Ib/II study, recruit infected volunteers. If the reduction in viral load can be replicated in a larger population, that would allow HIV-v to be registered as a therapeutic vaccine, to be administered as soon as someone was confirmed as HIV-positive. That would take away the need for treatment with anti-retrovirals, Stoloff said. Apart from quashing symptoms of HIV infection, the risk of transmission would be reduced. It would also be far less burdensome for health care systems, since a single injection would replace the daily administration of tablets and the constant monitoring that is necessary with anti-retroviral drugs.

Evidence from the Phase Ib/II trial is that the HIV-v vaccine could also help people currently receiving anti-retroviral drugs. Although none of the subjects in the trial was being treated with anti-retrovirals, those with the lowest CD4 counts had the biggest increase in CD4 counts after administration of the HIV-v vaccine. However, Stoloff said it would be difficult to differentiate the effect of the vaccine and the effect of retro-virals in a clinical study. "We would expect people to be able to drop anti-retroviral drugs, but this is not a good trial study, because you must see the immune system actually helping to fight infection," Stoloff said. The question of how long the effect of a single immunization lasts remains to be answered, but Stoloff believes it could be between five and 10 years

SEEK also said HIV-v could act as a prophylactic to prevent HIV transmission in the first place. However, Stoloff noted this is a higher risk and far lengthier route to getting an approval, with up to 10 years of follow-up required.

Apart from monitoring blood viral load and CD4 count in the Phase Ib/II trial, the activation of T- and B cells in response to the vaccine was assessed by measuring interferon gamma and IgG levels.

"The results demonstrate that after a single immunization the HIV-v vaccine produces a very strong response from both the antibody and T-cell immune systems, to the conserved regions [of HIV] only," claimed Wilson Caparros Wanderley, CSO of SEEK.

The HIV-v vaccine combines four peptide sequences from the VPR, VIF, REV and NEF conserved protein regions of the virus. SEEK said those are present in more than 5,600 different HIV strains. The vaccine is manufactured synthetically, at low cost.

Wow! Interesting to say the least. Just s single immunization confers lasting results for up to 5-10 years. I am definitely excited to see the results from the phase 3 trials once data becomes available.

There are many good HAART regimens with limited toxicity and well known side effect profiles. Why is a relatively untested vaccine preferable?

One of the nice things about HAART is that it only lasts for a limited amount of time in your body -- so if something goes wrong you can just stop taking it and switch to something else. What would be your option here?

This would be clearly better than meds. Even the most recent meds cause side-effects, and we don't know what they may cause after 20, 30 years. Besides, most people don't have access to them, but to old, cheap meds that cause all sorts of problems in the long-run. This vaccine, if it works, will do miracles.

Even the most recent meds cause side-effects, ...Besides, most people don't have access to them, but to old, cheap meds

um, please read some of the package insert information about the medications on the market. Most side effects affect 20% or less, so actually most meds do not produce side effects for the vast majority of patients. Also most people, in developed nations, do have access to newer meds.

Throughout the last 20 yrs of meds, my docs have consistently adjusted my meds to newer ones that are more effective with fewer sides. Thank goodness too! I used to take 32 pills and tablespoons of liquid meds daily; now I take 3 pills a day with no side effects. Every other person at my ASO that has been in treatment 15-20 years has also had their medications adjusted to fewer pills a day, less scheduling/food requirements, and less or no side effects.

I'm not saying the state of treatment is perfect nor that it can't be improved; but I don't see evidence that the situation as dire as you portray it.

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leatherman (aka mIkIE)

All the stars are flashing high above the seaand the party is on fire around you and meWe're gonna burn this disco down before the morning comes- Pet Shop Boys chart from 1992-2015Isentress/Prezcobix

Really people this was a phase one study done on 10 monkeys. I am all for hope and furthering treatment options but to think this will produce results in five years and hoping for "miracles" is a bit premature.

Really people this was a phase one study done on 10 monkeys. I am all for hope and furthering treatment options but to think this will produce results in five years and hoping for "miracles" is a bit premature.

This would be clearly better than meds. Even the most recent meds cause side-effects, and we don't know what they may cause after 20, 30 years. Besides, most people don't have access to them, but to old, cheap meds that cause all sorts of problems in the long-run. This vaccine, if it works, will do miracles.

It's great to be optimistic. But what supports the statement that it would be "clearly better than meds" in addition to pure optimism? That's why clinical trials are needed -- and even after the clinical trials as the drug or treatment is used in practice things pop up.

You know, I went on a pretty standard drug for osteoporosis -- it has been around a while and there is a lot of knowledge about how it typically works. So it is usually given in either weekly or monthly doses. Luckily I was on the weekly dose because I had an unusual reaction and it took months to stop.

So, optimism is good -- but let's not assume untested treatments are automatically better than tested known ones -- especially if they last a long time.

Apparently not. Im confusing my HiV vaccines. There was data just presented at IAS regarding a vaccine candidate that was able to achieve a functional cure in its test subjects (monkeys). Ive mixed up that vaccine with this one. My sincerest appologies.

um, please read some of the package insert information about the medications on the market. Most side effects affect 20% or less, so actually most meds do not produce side effects for the vast majority of patients. Also most people, in developed nations, do have access to newer meds.

Throughout the last 20 yrs of meds, my docs have consistently adjusted my meds to newer ones that are more effective with fewer sides. Thank goodness too! I used to take 32 pills and tablespoons of liquid meds daily; now I take 3 pills a day with no side effects. Every other person at my ASO that has been in treatment 15-20 years has also had their medications adjusted to fewer pills a day, less scheduling/food requirements, and less or no side effects.

I'm not saying the state of treatment is perfect nor that it can't be improved; but I don't see evidence that the situation as dire as you portray it.

I'm pretty sure that you know this, but the US and Western Europe are not the reality of people with HIV. Most people with HIV are in poor countries. Really, and that includes myself. I don't have access to the most modern medications, unless I have the money to pay for them, which I don't, at the moment. And really, don't you think 20% is still a lot?

Now, I'm not saying meds suck, or whatever. They save lives. But they are far from ideal and this kind of research is a game changer to end the epidemic.

Besides, doesn't taking a vaccine every other month (or even in years, like they predict) sound much better than taking meds daily? Geez, it's heaven.

It's great to be optimistic. But what supports the statement that it would be "clearly better than meds" in addition to pure optimism? That's why clinical trials are needed -- and even after the clinical trials as the drug or treatment is used in practice things pop up.

You know, I went on a pretty standard drug for osteoporosis -- it has been around a while and there is a lot of knowledge about how it typically works. So it is usually given in either weekly or monthly doses. Luckily I was on the weekly dose because I had an unusual reaction and it took months to stop.

So, optimism is good -- but let's not assume untested treatments are automatically better than tested known ones -- especially if they last a long time.

Now, now, I'm not popping the champagne just yet. I'm saying it "if it works as planned". I'm just hoping for it. If it does, it would be great, and regardless, I hope they keep pushing research like that.

um, please read some of the package insert information about the medications on the market. Most side effects affect 20% or less, so actually most meds do not produce side effects for the vast majority of patients. Also most people, in developed nations, do have access to newer meds.

Throughout the last 20 yrs of meds, my docs have consistently adjusted my meds to newer ones that are more effective with fewer sides. Thank goodness too! I used to take 32 pills and tablespoons of liquid meds daily; now I take 3 pills a day with no side effects. Every other person at my ASO that has been in treatment 15-20 years has also had their medications adjusted to fewer pills a day, less scheduling/food requirements, and less or no side effects.

I'm not saying the state of treatment is perfect nor that it can't be improved; but I don't see evidence that the situation as dire as you portray it.

I would say that the situation is a dire need since a large percentage of HIV+ patients in the world are in developing nations, and we all know that they don't have all the newer meds that us in developed nations have access to. And of course there's even worse.....those that cant even afford meds. Whereas a vaccine that can be administered once a year or less frequently, would be a game changer. Not just for survival purposes, but because its very inexpensive, efficient, ease of use, scalability, little to no toxicities, improves prevention etc.

Even though the package may say that "20% or less will experience side effects", I would still consider that a large number. That's as much as 1 in 5 ppl and of course that is in newer meds....What about the ppl that are using the older meds?

I do agree that treatment is not perfect, it can be improved and of course it was a game changer itself and has saved millions of lives, but there a lot of cons to meds... that a therapeutic vaccine would greatly improve on. A whole lot. And then of course there's all the U.S. ADAP waiting list that keep growing and growing and growing which adds more fuel to the fire...

Just as the article says: "Only 6.5 million out of an estimated 17million are eligible for anti-retroviral (ARV) treatment." which is sad.

Really people this was a phase one study done on 10 monkeys. I am all for hope and furthering treatment options but to think this will produce results in five years and hoping for "miracles" is a bit premature.

I think both Leatherman and I are reacting to the fact that newly diagnosed folks often seem to hover anxiously over the Research Forum looking for positive news.

While they are here they often soak up anything that reinforces their fear of starting on meds. But the reality is that the current first line meds and dosing schedules have benefitted from 16 years of experience and are really not a reason for obsessive fears. Many of the drugs are new and easier to take, but even older drugs are often given in better researched doses that make side effects less likely and more tolerable should they occur.

So yes, follow the research, be optimistic about future improvements and advances.

But don't allow that to stand in the way of starting the drugs when you need them. Odds are good that the biggest side effect you will experience is a dramatic drop in fear of HAART.

I'm not advocating a fear of HAART. Fact of the matter is there are side effects associated with HAART regardless of however small one may think that percentage is. I will be starting meds next week. In fact if I could start tonight I'd take a pill right this instant.

My thing is I'd prefer a therapeutic cure, functional cure or a cure on the whole like many others would rather than taking meds for a lifetime. I look forward to the day when some kind of cure is found so that this virus can be totally eradicated. It would be for the benefit of everyone worldwide. But hey if a cure is found within out lifetime if you prefer to not take it and continue on HAART that is your decission. But you shouldn't try to dampen the hopes of others because it seems you've given up hope on a cure being found for this virus.

I don't think it's assurbanipal's intention to dampen anyone's hope. What he and leatherman are saying is reasonable. You don't see many LTS following the news here, while many of use newly-infected are anxious for them. Things have improved, this has to be acknowledged. But we have to be patient for further improvements, while taking benefit from what's available today.

But hey if a cure is found within out lifetime if you prefer to not take it and continue on HAART that is your decission. But you shouldn't try to dampen the hopes of others because it seems you've given up hope on a cure being found for this virus.

Barbara please. Like you cared about curing millions in Africa a couple of months ago before you were diagnosed yourself. Or any of this.

But you shouldn't try to dampen the hopes of others because it seems you've given up hope on a cure being found for this virus.

Actually, to the extent I've expressed an opinion in the past, my posts have been rather optimistic about the possibility of a cure. I think something that is or feels like a cure will happen -- just the progress in the last five years since I started on meds has been very significant.

No, what I was suggesting is two things.

First, that the bar is now quite high for better treatments / cures simply because the current meds are so good, particularly if (unlike me) you start them while you still have a decent immune system.

Second, just because people are afraid of side effects under the current meds doesn't mean they should jump at something labeled as a cure that has not had the same rigorous testing that we, as a society, require of the current meds.

So what I was trying to dampen is the enthusiasm for unproven cures vs. proven meds. Further down that path lie quacks and denialists.

When the body of evidence is sufficient I'll be happy to ditch the meds -- I wouldn't even object to being part of accumulating that evidence if they'd take me (but usually they like younger and healthier for this sort of stuff).

I don't think it's assurbanipal's intention to dampen anyone's hope. What he and leatherman are saying is reasonable. You don't see many LTS following the news here, while many of use newly-infected are anxious for them. Things have improved, this has to be acknowledged. But we have to be patient for further improvements, while taking benefit from what's available today.

you're right. I don't want to dampen anyone's hopes. Heck I have a lot of hope myself. As I started out on the very first HIV med (AZT) two decades ago, I'm simply amazed at the progress, improvement and speed that has been made on treating HIV in such a short time. I've gone through 18 different meds, changing with the improvements over time, and think my current regimen of Truvada/Norvir/Reyetaz is incredible as, for me over the last 4 yrs, it has no side effects and has made me healthier than I've been in 30 yrs. Now I can only imagine how much the meds will continue to be improved and have hope that a theraputic vaccine - or even a cure! - might be in my future.

However, I do read that research news all the time. And time and time and time again, I've read how a vaccine or cure is "just around the corner". Thank god I wasn't skipping meds and waiting on the cure, or I would have died over a decade ago. Look through that research thread and you'll see that every year for years, there are multiple reports of how a cure or vaccine is almost here. ..... and yet here we all are still waiting. That's why I and others so often offer caution about getting your hopes pinned onto something being "the cure". It'll get here when it gets here, and until then the meds of today are 1000's of times better than the meds of 1991 and the meds of 2021 will be 1000's of times better than the meds of today.

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leatherman (aka mIkIE)

All the stars are flashing high above the seaand the party is on fire around you and meWe're gonna burn this disco down before the morning comes- Pet Shop Boys chart from 1992-2015Isentress/Prezcobix

^^thanks for the clarification. I guess I'm just a bit anxious. I agree that treatment has with meds ha's progressed my leaps and bounds. And I'm extremely grateful for what science has accomplished with the current meds we have. I start meds next week and if I don't I know I'll be dead in less than 2 years possibly.

But wheneva a cure is achieved be it in our lifetime it will be cause for joy.I just thnk that it is closer now than 10 years ago.

I start meds next week and if I don't I know I'll be dead in less than 2 years possibly.

I was in a hospital for 5 days with 5 tcells, PCP, VL in the millions, and 3 docs telling me to get my family up from NC to OH quickly before I died. That was like 16 years ago or so ... So hold onto hope, take your meds, and live a long happy productive life as we wait for the cure to be found.

it is a good point that newbies look at all this and have false hope so to speak. i remember when i was a complete newbie a year ago, i read all these research things and was like yeaaaaaa babyyyyyyy im gonna be cured in like a month. well then reality sets in ,some lts told me to chill and not get all hyped over this shit as it will only let me down. good advice i must say.so yea i read these posts a year later and dont get my hopes up at all. when it happens it happens but i no longer let this get the best of me anymore.yea im a bit more jaded a year into this.but what i wonder is where is all the break throughs from like ten years ago that should be coming into fruition now??

Before we get excited about this, let’s look closely at the press release issued by SEEK, a biotech company, which is the only information available about this vaccine. • The study was very brief, just 180 days or 6 months. (By contrast, the duration of the RV 144 Thai Trial was 33 months.) • There is no information provided about the starting point of trial volunteers relative to date of infection and disease progression: all information presented is based on changes in the ratio of viral load from the start date. • The sample size was very small: 55 volunteers divided into 5 groups—1 placebo, and four different vaccine protocols. Presumably, each group had only 11 participants; the 90% decrease in viral load was found only in group, which received a high dose plus adjuvant. • The finding that there was a difference of “one log (approx 90 percent) difference in viral count in HIV-infected people compared with placebo group” is an overstatement at best: according to the graph in the press release, the 90% decrease occurred on only one day, about 115 days into the trial. Most of the change in ratio is due to a spike in average VL load ratio in the 11-person placebo group on that day, rather than to a decrease in average VL ratio in the 11-person HDA group. At most points during the study, the results do not seem markedly different from those of clinical trials of other disappointing vaccine candidates which show 0.3 or greater log impact (e.g. FIT-06 and Vacc-4X). The SEEK CEO’s statement that this is the “first time ever that an HIV vaccine has shown such a meaningful result in a human clinical trial” is not accurate except for on that one day. • The PR provides no statistical analysis. There’s no way to know if the findings are statistically significant. • The data that is provided in the press release is only presented in graph form, and the two graphs lack detail. • The data has not been peer reviewed. • The PR states that “These data are being released to coincide with the 6th IAS Conference on HIV Pathogenesis, Treatment and Prevention,” and then describes how important this conference is. Despite the inference, the data were not presented at the conference in a poster or presentation. The company just issued a press release while the conference was happening and tried to make it sound like they presented there. • Finally, the foundation that the company says it is working with to develop an access plan for developing countries is headed by the CEO of the company. I think it is very unlikely that this company will produce an effective vaccine, therapeutic or preventative, in 3-5 years, if ever. But it is doing a good job of raising false hopes and, I imagine, money from gullible investors.